Urovant Sciences Reports Financial Results for the Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2019
Recent Business Highlights
- Announced positive top-line data results from the pivotal Phase 3 EMPOWUR study of vibegron in patients with overactive bladder
- Presented EMPOWUR study results at the
American Urological Association annual meeting in May - Initiated enrollment into the pivotal Phase 3 study of vibegron in men with OAB and benign prostatic hyperplasia (BPH), for which there is currently no approved treatment
- Gained general alignment with
U.S. Food and Drug Administration (FDA ) on proposed Phase 2a protocol for URO-902, our novel gene therapy product for OAB - Entered into a debt financing agreement with
Hercules Capital for up to$100 million
“Urovant Sciences achieved key milestones for several clinical programs for vibegron, an investigational beta-3 adrenergic agonist, driving us closer toward the goal of developing a leading specialty urology company,” said
Mr. Katkin continued, “We achieved another important clinical milestone with enrollment into the pivotal Phase 3 study of vibegron in men with OAB and BPH, an important supplemental program for vibegron as there is currently no approved treatment for concomitant OAB and BPH. Furthermore, we gained general alignment with the
Fiscal 2018 Financial Summary
For the year ended
Fourth Fiscal Quarter 2018 Financial Summary
For the quarter ended
Note to Investors
As previously announced, Urovant will hold a conference call to discuss 2018 fourth fiscal quarter and full fiscal year ended
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions; the Company’s expectations regarding its Phase 3 study of vibegron in men with OAB and BPH; and the Company’s expectations regarding its proposed Phase 2a protocol for URO-902.
The Company’s forward-looking statements are based on management’s current expectations and beliefs, and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted or expected. Although the Company believes that the assumptions underlying these forward-looking statements are reasonable, they are not guarantees and the Company can give no assurance that its expectations will be attained. Factors that could materially affect the Company’s operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to: the Company’s limited operating history and the fact that it has never generated any product revenue; the Company’s ability to achieve or maintain profitability in the future; the Company’s dependence on the success of its lead product candidate, vibegron; the Company’s reliance on its key scientific, medical or management personnel and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Company’s clinical trials for vibegron and URO-902 and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; the Company’s dependence on
UROVANT SCIENCES LTD. Condensed Consolidated Statements of Operations (unaudited; in thousands, except share and per share data) |
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Three Months Ended
March 31, |
Year Ended
March 31, |
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2019 | 2018 | 2019 | 2018 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development(1) | $ | 22,890 | $ | 16,430 | $ | 92,198 | $ | 32,359 | ||||||||
General and administrative(2) | 5,935 | 2,698 | 18,585 | 4,640 | ||||||||||||
Total operating expenses | 28,825 | 19,128 | 110,783 | 36,999 | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest expense, net | (259 | ) | — | (259 | ) | — | ||||||||||
Other income (expense) | 42 | 44 | (257 | ) | (38 | ) | ||||||||||
Loss before provision for income taxes | (29,042 | ) | (19,084 | ) | (111,299 | ) | (37,037 | ) | ||||||||
Provision for (benefit from) income taxes | (74 | ) | 11 | 47 | 37 | |||||||||||
Net loss | $ | (28,968 | ) | $ | (19,095 | ) | $ | (111,346 | ) | $ | (37,074 | ) | ||||
Net loss per common share—basic and diluted | $ | (0.96 | ) | $ | (0.95 | ) | $ | (4.43 | ) | $ | (2.16 | ) | ||||
Weighted average common shares outstanding—basic and diluted | 30,322,911 | 20,025,098 | 25,145,211 | 17,124,659 |
(1) |
Includes $409 and $367 of share-based compensation during the three months ended March 31, 2019 and 2018, respectively, and $1,296 and $2,477 of share-based compensation during the year ended March 31, 2019 and 2018. |
|
(2) |
Includes $941 and $370 of share-based compensation during the three months ended March 31, 2019 and 2018, respectively, and $2,682 and $694 of share-based compensation during the year ended March 31, 2019 and 2018. |
UROVANT SCIENCES LTD. Condensed Consolidated Balance Sheets (unaudited; in thousands) |
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March 31, 2019 | March 31, 2018 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 85,353 | $ | 7,194 | |||
Restricted cash | 243 | — | |||||
Prepaid expenses and other current assets | 12,914 | 5,196 | |||||
Total current assets | 98,510 | 12,390 | |||||
Furniture and equipment, net | 923 | 510 | |||||
Restricted cash, net of current portion | 600 | — | |||||
Other assets | 88 | 84 | |||||
Total assets | $ | 100,121 | $ | 12,984 | |||
Liabilities and Shareholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,925 | $ | 833 | |||
Accrued expenses | 9,877 | 3,595 | |||||
Due to Roivant Sciences Ltd. | 15 | 1,482 | |||||
Total current liabilities | 11,817 | 5,910 | |||||
Long-term debt | 13,534 | — | |||||
Total liabilities | 25,351 | 5,910 | |||||
Total shareholders' equity | 74,770 | 7,074 | |||||
Total liabilities and shareholders' equity | $ | 100,121 | $ | 12,984 |
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Source:
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com